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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (IRVINE) XEN 45 GTS; IMPLANT, EYE VALVE
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ALLERGAN (IRVINE) XEN 45 GTS; IMPLANT, EYE VALVE Back to Search Results
Catalog Number 5507-001
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2019
Event Type  malfunction  
Manufacturer Narrative
A review of the device history record has been initiated.If any deviations or non-conformance's are found, a supplemental medwatch will be submitted.Clarification to model: serial number: (b)(4), lot number: 62719.
 
Event Description
Healthcare professional reported xen®45 gts implant was too short and it is not possible to implant it to the left eye.The affected device was removed by conjunctival via (way/path).Surgery was completed with another xen.There was no eye injury.
 
Event Description
Healthcare professional reported xen®45 gts implant was too short and it is not possible to implant it to the left eye.The affected device was removed by conjunctival via (way/path).Surgery was completed with another xen.There was no eye injury.
 
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Brand Name
XEN 45 GTS
Type of Device
IMPLANT, EYE VALVE
Manufacturer (Section D)
ALLERGAN (IRVINE)
2525 dupont drive
irvine CA 92612
MDR Report Key8856900
MDR Text Key153144974
Report Number3011299751-2019-00192
Device Sequence Number1
Product Code KYF
Combination Product (y/n)N
PMA/PMN Number
K161457
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Catalogue Number5507-001
Was Device Available for Evaluation? No
Date Manufacturer Received07/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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